Advanced Medical Optics
Amadeus Operator Manual V3.4
Operator Manual
115 Pages
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Page 1
Amadeus Microkeratome Operator Manual Version 3.4 for Software 2.00
A MADEUS Microkeratome Title Part number Revision Software version Date of print Products
A MADEUS Microkeratome – User manual SIS-100360 (letter); SIS-100362 (A4) Version 3.4 2.00 September 11, 2003 A MADEUS M ICROKERATOME , type MK32.
History
Version 3.2: first published issue (January 2001) Version 3.3: published August 2002
Author
TST Consulting GmbH, Bern, Switzerland
Disclaimer
Please note that while every effort has been made to ensure that the data provided in this document is accurate, it is the policy of SIS to continuously improve the operating performance and overall quality of its medical devices. Accordingly, the information, figures, illustrations, tables, specifications and schematics herein are subject to change without notice.
Copyright
© 2000 Surgical Instrument Systems Ltd. This manual contains proprietary information. All rights are reserved. This document may not in whole or in part be copied, photocopied, reproduced, translated or reduced to any electronic medium or machine readable form without prior consent in writing from Surgical Instrument Systems Ltd.
Trademarks
A MADEUS, S URE P ASS are trademarks of SIS, A MO is trademark of Advanced Medical Optics. Other trademark names are used in an editorial fashion only with no intention of infringement of the trademark of the respective owner.
Manufacturer
Surgical Instrument Systems Ltd. (SIS), P.O. Box, CH-2501 Biel, Switzerland; www.sisltd.ch
Licensee and distributor
Advanced Medical Optics, Inc. 1700 East St. Andrew Place, Santa Ana, CA 92705; www.amadeusrefractive.com
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A MADEUS Microkeratome
z0120 65RM
The AMADEUS Microkeratome is designed and built in accordance with the present state UL 2601-1 of technology and the recognised rules of safety engineering. Microkeratome Model MK32 The AMADEUS Microkeratome, model MK32 adheres to the Class II Medical Device standard (MDD, 93/42/EEC). Medical electrical Equipment With respect to electric shock, fire, mechani- SGS Yarsley International Certification Services Ltd. cal hazards only UK-Somerset BS22 0WA In accordance with Certificate Number C50802 CAN/CSA C22.2 No. 601.1 and UL 2601-1
Caution Federal (U.S.) law restricts this device to sale by, or on the order of, a physician.
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A MADEUS Microkeratome
Customer service information For service assistance and to order accessories or replacement parts, call Advanced Medical Optics, Inc. customer service department. AMO Customer Service USA - Equipment/Supplies
Phone +1-800-366-6954 +1-800-449-3060
Canada - Technical Support
Phone +1-800-668-6477 +1-800-449-3060
Japan
Phone +81-3-5402-8930 FAX +81-3-5402-8978
Asia Pacific
Local AMO representative
Europe, Africa and Middle East - AMO Surgical System Services
Local AMO representative Phone +49-7423-729-444 E-mail [email protected]
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A MADEUS Microkeratome
Description The A MADEUS Microkeratome is a medical instrument exclusively designed for use in ophthalmic surgery. This Operators' Manual provides important information regarding the use of the A MADEUS Microkeratome. Physicians using the A MADEUS Microkeratome should read the manual thoroughly prior to operating the device. Additional information can be obtained from your local AMO representative.
Unique features of the A MADEUS Microkeratome
• Elegant and simple to use touch screen Control Unit • Single-handed operation • Visual contact while creating the flap • Integrated blade loading system • Vacuum level displayed on LCD display • Fully enclosed gearless drive eliminates risk of gear jams • Advanced design to eliminate on-eye assembling of dovetails or gears • One-way assembly to reduce the risk of pre-operative error • Multiple safety checks to ensure consistently smooth, high quality keratectomies
Indications for Use
The A MADEUS Microkeratome is a precision manufactured instrument specifically designed for cutting a precise corneal disc of preselected thickness and diameter. This device is intended for use in performing lamellar corneal resections.
Site Preparation, Unpacking and Installation
Unpacking and installation should be done only after reading this manual thoroughly. Please check all items relating to the device against the packing list (see Components list on page 97 for details). Each item should be inspected and any damage noted and reported within 30 days of reception to the local AMO representative
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A MADEUS Microkeratome
How to use this manual Do not use the A MADEUS Microkeratome without having a thorough understanding of instrument assembly, sterilization procedures, operation and all components, functions, controls and limitations of the instrument. This manual is about using the A MADEUS Microkeratome. It does not give instructions on clinical procedures to do keratoctomies. The manual is divided into 7 chapters: Chapter 1
Components on page 1 gives you an overview on the components of the A MADEUS Microkeratome. It defines the parts and their names.
Chapter 2
Safety instructions on page 11 specify the safety icons used in this manual and include guidelines concerning appropriate handling of the instrument. Read this chapter very carefully.
Chapter 3
Procedure on page 17 instructs you how to assemble, set up and use the instrument for surgery. Cleaning is also covered.
Chapter 4
Control Unit description on page 49 details the user interface (display, messages etc.) and how to set parameters.
Chapter 5
Trouble shooting on page 65 gives instructions to cope with general trouble and how to interpret the messages on the display.
Chapter 6
Care and maintenance on page 85 provides instructions concerning the backup battery, software update etc.
Chapter 7
The Appendix on page 97 provides the functional specifications, the component list, a short glossary, the symbols used on the instrument, warranty information and a table to record owner data.
Typographical conventions
Italic style
is used for highlighting references to other locations in this document.
This font
names items of the user interface on the touch screen (window headings, buttons etc.)
S MALL CAPS
Small caps are used for branded names such as A MADEUS Microkeratome.
Component Name Names of product components are capitalized is used for on-screen messages.
This font
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A MADEUS Microkeratome
Contents Customer service information...iv Description... v How to use this manual...vi
Chapter 1:
Components ... 1 Control Unit... 2 Handpiece... 3 Suction Unit... 4 Blade Holder... 5 Motor Unit... 6 Control Pedals... 7 Accessories... 8 Disposable accessories... 10
Chapter 2:
Safety instructions ... 11 Notes on safety and icons... 11 Defined purpose of AMADEUS Microkeratome... 11 Basic safety information... 12 Operational considerations... 12 Operational user qualification... 12 Single-use disposable accessories... 12 Power failure and vacuum... 13 Handling... 13 Cleaning... 14 Maintenance... 14 Check the guiding tracks daily... 15
Chapter 3:
Procedure ... 17 Primary decisions... 17 Daily test of guiding tracks... 17 Assembly of AMADEUS system... 18 Inserting the SUREPASS sterilized blade... 21 Handpiece assembly... 23 Fasten Blade Holder to Motor Unit... 23 Apply the Suction Unit... 24
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A MADEUS Microkeratome Connect the vacuum tube... 26 Surgery... 27 Check operation parameters... 28 Surgery procedure... 31 Dismantling... 34 Dismantling the Handpiece... 34 Prepare for storage... 34 Cleaning and sterilization... 35 General Considerations... 35 Cleaning and disinfecting mechanical and electrical components 37 Cleaning Suction Unit and Blade Holder... 40 Sterilization... 48
Chapter 4:
Control Unit description ... 49 Operator-machine interface... 49 Appearance of the display... 49 Acoustic signals... 50 Status messages... 50 Define numeric values... 50 Select from predefined values... 51 Confirmation and withdrawal... 51 Values not permitted... 51 Use of the Pedals (foot switches)... 52 Customizing... 53 General cutting parameters... 56 Zero Position Stop... 56 Suction OFF... 56 Vacuum loss limit... 57 Smooth fall mode... 58 Vacuum mode - full... 59 Vacuum mode - controlled... 60 System Information... 61 Self tests... 62
Chapter 5:
Trouble shooting ... 65 Displayed messages... 66 General trouble... 68 De-blocking Handpiece... 70 Messages... 72 Most frequently appearing messages... 72 Complete list of messages... 74
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A MADEUS Microkeratome Chapter 6:
Care and maintenance ... 85 Master reset... 85 Reset User stroke counter... 85 Maintain Handpiece... 86 Warnings regarding expiring of service interval... 87 Maintain Control Unit... 88 Maintain Suction Unit... 88 Maintain Blade Holder... 88 Remove and restore back plate... 89 Maintain the battery... 90 Replacing fuse... 93 Software update... 94
Chapter 7:
Appendix... 97 Components list... 97 Required disposable accessories and options... 97 Technical specifications... 98 Glossary... 100 Symbols on the instrument... 101 Warranty information... 102 Owner Data... 104
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A MADEUS Microkeratome
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A MADEUS Microkeratome
Components
Components The complete A MADEUS Microkeratome system consists of these major items: • Control Unit integrating a control computer, a touch screen, backup battery and backup vessel for the vacuum. • Handpiece with Blade Holder and the Suction Unit placed on the eye, and the Motor driving the Blade of the microkeratome. • Pedals to control the operation alternatively to touching the screen. • Vacuum tubes and blades are single-use accessories
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A MADEUS Microkeratome
Components
Control Unit The Control Unit comprises an integrated computer system, which stores cutting parameters, controls activation of the microkeratome motors, provides audible and visual signals for safeguard monitoring of the surgery, and provides a measurement and regulation of the vacuum. The Control Unit includes power supply with back up battery, vacuum pump and vacuum backup vessel, a computer driven controller with a touch screen interface. Fig. 1: Front view 1 2 3 4 5
Display with touch screen Connector for Handpiece Holster for Handpiece Connector for vacuum tube Connector for Pedals
3 1
2
4
5
Fig. 2: Rear view 1 2 3 4 5
Mains switch Mains input plug Rear connector for Pedals Name plate Fuse box
5 4
1 2
3
2
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A MADEUS Microkeratome
Components
Handpiece The Handpiece creates the keratectomy: The Motor Unit (1) moves the Blade Holder (5) across the Suction ring (7) of the Suction Unit (3). The Motor Unit also oscillates the Blade (6) within the Blade Holder (5). Motor Unit (1) and Suction Unit (3) are held together by the locking pins of the Tappet (4).
Fig. 3: Handpiece in exploded view 1 2 3 4 5 6 7
2 4
Motor Unit Connection cable Suction Unit ‘locks’ into Motor Unit Tappet with locking pins Blade Holder Blade (to be inserted) with plastic pieces for handling Suction ring
1 3
7
5 6
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A MADEUS Microkeratome
Components
Suction Unit The Suction ring (1) comprises two concentric axially displaced conical surfaces with recess. When applied to the eye the Suction ring forms a vacuum chamber. The Suction Unit is connected to the Control Unit via disposable silicone tube at (2). Fig. 4: Suction Unit 1 2 3 4
Suction ring Vacuum connection Tappet ‘locks’ Suction Unit to Motor Unit and releases tension on power cable Indication of flap diameter (stamp): 8.5, 9.0, 9.5 or 10 mm
3
4 2 4
1
Fig. 5: Suction ring 1 2
Tracks for Blade Holder Indication of flap diameter (engraved): 8.5, 9.0, 9.5 or 10 mm
1
4
2
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A MADEUS Microkeratome
Components
Blade Holder The Blade Holder houses the disposable S URE P ASS cutting blade and is placed in a linear guiding rail that moves across the cornea. The cutting action is not gear-driven, thus providing smooth blade movement across the cornea and less wear and tear on the Handpiece. Absence of gears also eliminates the potential of engagement of foreign materials in the gears that can cause cutting complications or deposit foreign materials on the cornea. The Blade Holder comprises an applanation plate (4) that controls the depth of the cut. The blade oscillates in the direction of the cutting edge; parallel to the level of the applanation plate that can offer various flap thicknesses depending on the Blade Holder selected. Fig. 6: Blade Holder 1 2 3 4 5 6 7 8
2
Entry for motor shaft Head face Spring loaded buttons (on both sides) Applanation plate Slot to insert blade Railings fitting into the guiding tracks of the Suction Unit Flap channel (where the blade acts) Indication of flap thickness (here: 180 micron)
8 1
5 3
4
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A MADEUS Microkeratome
Components
Motor Unit Two separate motors provide independent movement of the cutting blade. One motor controls forward and reverse movement of the blade across the cornea while the second motor oscillates the blade. The cable that connects the motors to the Control Unit is highly flexible to avoid force on the Handpiece during cutting action. Fig. 7: Motor Unit 1 2 3
Rails for fixation in Holster at the Control Unit Shaft of oscillation motor Advance motor link arm for advancing and retreating the Blade
1
3 2 If the advance motor link (3) is not in its locked position as shown here, the Motor Unit can not be assembled with the Suction Unit.
$ Insert the Flying Tappet found in the Service Kit to reset the link arm to its locked position.
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A MADEUS Microkeratome
Components
Control Pedals The two Pedals provide the principle command control for activation and termination of the microkeratome cutting procedure. In the event of malfunction, the touch screen serves as the backup control interface. The activation Pedal (green) initiates vacuum and microkeratome cutting action. The ‘break’ Pedal (red) stops the blade action immediately. The Pedals allow the surgeon to proceed or terminate the microkeratome operation as condition allow. This is indicated on the display. Fig. 8: Pedals (foot switches) 1 2 3 4
3 4
Red Pedal Green Pedal Fixed connection between the Pedals Connection cable to the Control Unit
1 2
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A MADEUS Microkeratome
Components
Accessories Fig. 9: Equipment storage and carrying case 1 2 3 4 5 6 7
Inset for manual (not on picture) Inset for Motor Unit with cable. Pedals Sterilization box Handpiece Holster Mains cable Control Unit
2
5 7
3 6 4
# Caution
When storing the Pedals do not excessively bend the cables.
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A MADEUS Microkeratome
Components
Fig. 10: Sterilization and Storage box for two Suction Units and two Blade Holders.
Fig. 11: Blade remover
Use the Blade Remover to push the used blade out of the Blade Holder. This tool is part of the Service Kit.
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A MADEUS Microkeratome
Components
Disposable accessories Fig. 12: SUREP ASS disposable single-use blade (Box of 10)
Fig. 13: Sterile vacuum tube - unpacked (Box of 10) 1 2 3
3
Reservoir with Velcro (to be attached to Control Unit) Connector to Control Unit Tube to be connected to Handpiece
2
1
10
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